The continued access study of the InterGraft Venous Anastomotic Connector (Venous InterGraft Continued Access Study, or 'VIG-CAS') allows for continued enrollment of subjects while the marketing application is being prepared and subsequently reviewed by FDA. The VIG-CAS will include the same patient population, follow-up schedule, and study endpoints as the VIG pivotal study.
The VIG-CAS is a multicenter, prospective, single-arm study that will include up to 15 subjects contributed from up to 5 study sites that previously participated in the VIG pivotal study. No new investigators will be included. All subjects will be assigned to treatment with the VIG and a standard sutured arterial anastomosis for implantation of an arteriovenous graft (AVG) for hemodialysis. The selection criteria (patient population), follow-up schedule, and study endpoints are the same as those used in the pivotal study. Study data will be collected up to the point at which each subject has completed the final 6-month follow up or experienced a terminal study event.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Small skin incisions will be made for tunneling the graft under the skin in a standard manner. The VIG device is provided pre-loaded within a customized catheter-based delivery system for over-the-wire delivery. The VIG is inserted through an introducer sheath placed in the target vein so that the 'vessel end' of the VIG is deployed within the vein, and the 'graft end' extends out of the vein for connection to the graft. Delivery and deployment will be performed under fluoroscopic guidance. The VIG will be deployed first, connected to the AVG, then the graft and VIG will be flushed and clamped. The arterial anastomosis will then be created using a standard suturing method.
Trinity Research Group, LLC
Dothan, Alabama, United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States
Cumulative Patency
Percentage of subjects free from loss of access of the AVG for hemodialysis
Time frame: 6 months
Acute Device Success
AVG flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery
Time frame: At implant
Primary Unassisted Patency
Percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency
Time frame: 6 months
Time to First Cannulation
Time from initial access placement to the first graft cannulation for hemodialysis
Time frame: 6 months
Interventions Required to Maintain Secondary Patency
Number and type of interventions required to maintain secondary patency. One or more intervention-types (e.g., angioplasty, thrombectomy, etc.) may have been performed during a single intervention surgery.
Time frame: 6 months or up to time of early exit from the study, whichever occurs first.
Protocol-defined Serious Adverse Events (SAEs)
Protocol-defined SAEs (secondary endpoint) include the following: death, emergent surgery, AVG infection requiring treatment (e.g., prolonged or intravenous antibiotic therapy), significant bleeding (defined as bleeding requiring treatment), and pseudoaneurysm.
Time frame: 6 months or up to time of early exit from the study, whichever occurs first.
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